[12 June 2018] Why This Biotech Company Is Bounding Closer To A Breakout
ALLISON GATLIN6/12/2018
Sage Therapeutics ( SAGE) bounded closer to a breakout Tuesday after the biotech company outlined its expedited path to approval for a depression treatment.
On the stock market today, Sage shares catapulted 19.6% to close at 175.75. The stock is consolidating with a buy point at 188.92.
The Food and Drug Administration will allow Sage to run a single additional study of its drug, SAGE-217, in major depressive disorder. U.S. regulators also said Sage could use an ongoing study in postpartum depression to support approval for that use.
Both studies will look at dosing SAGE-217 over a short period of time as a depression treatment, Chief Executive Jeff Jonas said in a written statement. Another study will look at episodic use of SAGE-217 in recurrent or new major depressive episodes
"We are exploring the potential for patients with (major depressive disorder) to feel well within days, with just a two-week course of treatment — similar to how antibiotics are used today — instead of enduring long-term chronic treatment," he said.
Depression Treatment Plans The FDA's findings allow the company to go ahead with its plans for the drug. Sage expects to have data from an ongoing study in postpartum depression in the fourth quarter. The study is evaluating SAGE-217 vs. a placebo in 140 patients.
The biotech company also plans to begin a Phase 3 study testing SAGE-217 in major depressive disorder in the second half of 2018. Researchers will look at two doses of SAGE-217 compared with a placebo in 450 patients.
"We believe a medicine with rapid onset and robust response could be truly paradigm shifting," Jonas said. "SAGE-217, if successfully developed and approved, may rewrite the textbook on how the tens of millions of people suffering from (major depressive disorder) are treated, ultimately turning depression into a disorder, not an identity."
FDA officials also support Sage's plan to look at SAGE-217 as a treatment for episodes of depression. Sage plans a study of 300 patients for six months and 100 patients for a year.
Sage also expects the FDA to approve its drug, brexanolone, as a postpartum depression treatment by year's end.
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